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2016-05-13

Swedish Orphan Biovitrum AB: Alprolix® (rFIXFc) approved in the EU for the treatment of haemophilia B

First Fc Fusion therapy approved for haemophilia B in the EU to
provide extended protection against bleeds

Swedish Orphan Biovitrum AB (publ) (http://www.sobi.com/) (Sobi™)
(STO: SOBI) and Biogen (http://www.biogen.com) (NASDAQ: BIIB) today
announced that the European Commission (EC) has approved Alprolix®
(rFIXFc), their extended half-life therapy, for the treatment of
haemophilia B in all 28 European Union (EU) member states and
maintained its orphan designation. Alprolix is the only recombinant
factor IX Fc Fusion protein therapy for haemophilia B to offer people
in the EU prolonged protection against bleeding episodes with fewer
prophylactic injections.

Alprolix is indicated for both on-demand and prophylaxis treatment of
people with haemophilia B in all ages. Prophylactically, it can be
administered with an initial dose every seven days or every 10 days
with the ability to adjust the dosing interval based on individual
response.

"With the approval of Alprolix, people with haemophilia B in Europe
now have the potential to experience prolonged protection from bleeds
with fewer injections," said Krassimir Mitchev, M.D., Ph.D., vice
president and medical therapeutic area head of Haemophilia at Sobi.
"We are working to make Alprolix available in Europe as quickly as
possible. Along with Biogen, we're excited to continue offering
innovative therapies to people with haemophilia around the world."

The EC's approval of Alprolix was based on results from two global
phase 3 clinical trials that demonstrated the efficacy, safety and
pharmacokinetics of Alprolix for haemophilia B: the pivotal B-LONG
study for previously treated adults and adolescents, and the Kids
B-LONG study for previously treated children under age 12. The
adverse drug reactions with an incidence of ? 0.5 percent for
Alprolix were nasopharyngitis (common cold), influenza, arthralgia
(joint pain), upper respiratory tract infection, headache, and
hypertension. The majority of these events were judged as not related
or likely not related to study drug.

"Alprolix has become a meaningful treatment advance for people living
with haemophilia B in countries where it is approved and is backed by
robust clinical data and the longest real-world experience of any
prolonged circulation factor IX therapy to date." said Gilmore
O'Neill, M.D., senior vice president Drug Innovation Units at Biogen.
"We're proud to bring the European haemophilia community one of the
first treatment advances in nearly 20 years, and believe the
availability of extended half-life therapies in Europe will change
the way that many approach treatment."

Sobi and Biogen collaborate on the development and commercialisation
of Alprolix for haemophilia B. Sobi has final development and
commercialisation rights in the Sobi territory (essentially Europe,
North Africa, Russia and most Middle Eastern markets). Biogen leads
development and manufacturing for Alprolix and has commercialisation
rights in North America and all other regions in the world excluding
the Sobi territory.

---

About Alprolix®
Alprolix® is a recombinant clotting factor therapy developed for
haemophilia B by fusing factor IX to the Fc portion of immunoglobulin
G subclass 1, or IgG1 (a protein commonly found in the body). This
technology enables Alprolix to use a naturally occurring pathway to
prolong the time the therapy remains in the body. While Fc fusion has
been used for more than 15 years, Sobi and Biogen are the first
companies to utilise it in the treatment of haemophilia.

Alprolix is currently approved for the treatment of haemophilia B in
the United States, European Union, Canada, Japan, Australia, New
Zealand, and other countries, to provide prolonged protection from
bleeds. As with any infused protein, allergic type hypersensitivity
reactions and development of inhibitors may occur following
administration of Alprolix.

About Haemophilia B
Haemophilia B is caused by having substantially reduced or no factor
IX activity, which is needed for normal blood clotting.[1]
(http://connect.ne.cision.com#_edn1) The World Federation of
Hemophilia estimates that approximately 28,000 people are currently
diagnosed with haemophilia B worldwide.[2]
(http://connect.ne.cision.com#_edn2)

People with haemophilia B may experience bleeding episodes in joints
and muscles that cause pain, decreased mobility and irreversible
joint damage. In the worst cases, these bleeding episodes can cause
organ bleeds and life-threatening haemorrhages. Infusions of factor
IX temporarily replace clotting factors necessary to resolve bleeding
and, when used prophylactically, to prevent new bleeding episodes.1

About Sobi™
Sobi is an international specialty healthcare company dedicated to
rare diseases. Sobi's mission is to develop and deliver innovative
therapies and services to improve the lives of patients. The product
portfolio is primarily focused on Haemophilia, Inflammation and
Genetic diseases. Sobi also markets a portfolio of specialty and rare
disease products across Europe, the Middle East, North Africa and
Russia for partner companies. Sobi is a pioneer in biotechnology with
world-class capabilities in protein biochemistry and biologics
manufacturing. In 2015, Sobi had total revenues of SEK 3.2 billion
(USD 385 M) and about 700 employees. The share (STO: SOBI) is listed
on NASDAQ OMX Stockholm. More information is available at
www.sobi.com.

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world's oldest independent biotechnology
companies and patients worldwide benefit from its leading multiple
sclerosis and innovative haemophilia therapies. For more information,
please visit www.biogen.com and follow us on Twitter.

Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the potential benefits of Alprolix® in haemophilia
B, including any changes in the treatment approach for patients with
haemophilia B. These forward-looking statements may be accompanied by
such words as "anticipate," "believe," "could," "estimate," "expect,"
"forecast," "intend," "may," "plan," "potential," "project,"
"target," "will" and other words and terms of similar meaning. You
should not place undue reliance on these statements. These statements
involve risks and uncertainties that could cause actual results to
differ materially from those reflected in such statements, including
uncertainty of success in commercialization of Alprolix, which may be
impacted by, among other things, slower than anticipated acceptance
of Alprolix by patients and the medical community, competition in the
hemophilia market, the effectiveness of sales and marketing efforts,
dependence on third party collaborations and collaborators, problems
with the manufacturing process for Alprolix, the occurrence of
adverse safety events, difficulties in obtaining or changes in the
availability of reimbursement for our products, failure to obtain
regulatory approvals in other jurisdictions, failure to protect
intellectual property and other proprietary rights, product liability
claims and the other risks and uncertainties that are described in
the Risk Factors section of our most recent annual or quarterly
report and in other reports we have filed with the U.S. Securities
and Exchange Commission (SEC). Any forward-looking statements speak
only as of the date of this press release and we assume no obligation
to update any forward-looking statements, whether as a result of new
information, future events, or otherwise.

For more information please contact:

Sobi
Media relations Investor relations
Oskar Bosson, Head of Jörgen Winroth, Vice
Communications President, Head of Investor
Relations
T: +46 70 410 71 80 T: +1 347-224-0819, +1 212
-579-0506, +46 8 697 2135
oskar.bosson@sobi.com jorgen.winroth@sobi.com

Biogen
Media contact Investor relations
Todd Cooper Benjamin Strain
+1-781-464-3260 1-781-464-2442
public.affairs@biogen.com IR@biogen.com

Benjamin Russell
+41 41 392 1702
publicaffairs.eu@biogen.com

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[1] (http://connect.ne.cision.com#_ednref1) World Federation of
Hemophilia. About Bleeding Disorders - Frequently Asked Questions.
Available at: http://www.wfh.org/en/page.aspx?pid=637#Difference_A_B.
Accessed on: February 11, 2016.

[2] (http://connect.ne.cision.com#_ednref2) World Federation of
Hemophilia. Report on the Annual Global Survey 2013. Available at:
http://www1.wfh.org/publications/files/pdf-1591.pdf. Accessed on:
February 11, 2016.

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http://news.cision.com/swedish-orphan-biovitrum-ab/r/alprolix---rfixfc--...
http://mb.cision.com/Main/14266/2008467/515390.pdf

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